UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051568 |
|---|---|
| Receipt number | R000056597 |
| Scientific Title | A clinical study on the efficacy and safety of essential oil fragrance for psychogenic urinary frequency |
| Date of disclosure of the study information | 2023/07/10 |
| Last modified on | 2023/07/10 15:07:57 |
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Basic information
Public title
A clinical study on the efficacy and safety of essential oil fragrance for psychogenic urinary frequency
Acronym
Clinical trial of essential oils for psychogenic urinary frequency
Scientific Title
A clinical study on the efficacy and safety of essential oil fragrance for psychogenic urinary frequency
Scientific Title:Acronym
Clinical trial of essential oils for psychogenic urinary frequency
Region
| Japan |
Condition
Condition
psychogenic urinary frequency
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate whether shell ginger and citrus aromatherapy for two weeks are effective for women with psychogenic urinary frequency.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of urinations during the day
Key secondary outcomes
plasma serotonin concentration
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Shell ginger aroma
Interventions/Control_2
shikuwasa aroma
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Women who are troubled by psychogenic urinary frequency, who tend to get nervous at work or school, and find it difficult to refrain from going to the bathroom until break time. Psychogenic pollakiuria occurs at least once a week.
Key exclusion criteria
(1) Subjects who are undergoing treatment for psychogenic frequent urination or depression, or who are taking supplements for them
(2) Within 6 months after completion of treatment for psychogenic frequent urination or depression
(3) Subjects with dysuria including frequent urination even on holidays or at night
(4) Things that carry out aromatherapy
(5) Those who have difficulty communicating
(6) Others that the attending physician deems inappropriate for registration in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Kitakami Central Hospital/Southern Knights' Laboratory
Division name
Urology
Zip code
9040113
Address
1-1-823 Miyagi, Chatan, Okinawa, Japan
TEL
09049987459
sugaya@sklabo.co.jp
Public contact
Name of contact person
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Kitakami Central Hospital/Southern Knights' Laboratory
Division name
Urology
Zip code
9040113
Address
1-1-823 Miyagi, Chatan, Okinawa, Japan
TEL
09049987459
Homepage URL
https://sklabo.co.jp/
sugaya@sklabo.co.jp
Sponsor or person
Institute
Okinawa Industry Promotion Public Corporation.
Institute
Department
Personal name
Funding Source
Organization
Okinawa Industry Promotion Public Corporation.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawahara Urology Ethics Review Board
Address
73-3 Nishimochida, Aira, Kagoshima, Japan
Tel
0995-64-5181
yamashita.hami@kawahara.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 10 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056597
